New York, Aug 26 : University Hospitals (UH) in the US has been selected as the clinical site to test for the Phase 2/3 of a possible Covid-19 vaccine — BNT162b2 — sponsored by the US-based pharmaceutical major Pfizer and German biotech firm BioNTech.
UH Cleveland medical centre’s study site is one of approximately 120 clinical investigational sites around the world that will collectively enrol up to 30,000 participants.
This vaccine is one of the most advanced candidates in the BNT162 programme currently being evaluated in the US and Germany and recently received fast track designation from the US Food and Drug Administration (FDA).
“We are expecting a shipment of the experimental vaccine and initiation of the trial in the next week,” said Daniel I. Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical Centre.
There is presently no cure for the highly contagious novel coronavirus that causes Covid-19 and the best plan of attack is to find a vaccine that can help protect people from getting it in the first place.
“The trials we are preparing to conduct are especially significant because if proven safe and effective, and the vaccine receives regulatory approval, Pfizer and BioNTech expect to be able to manufacture up to 100 million doses by the end of 2020,” said researcher Robert Salata from UH.
The study aims to enrol non-pregnant adults from 18 to 85 years.
The trial’s primary endpoints will be the prevention of Covid-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of Covid-19 regardless of whether participants have previously been infected by SARS-CoV-2.
The researchers said that secondary endpoints include the prevention of severe Covid-19 in those groups.
“The goal, as always, is to ensure access to the most novel treatments for our UH patients and the communities we serve,” Dr. Simon concluded.
Recently, Pfizer and BioNTech announced positive results for the Phase 1 trial of their second Covid-19 vaccine candidate, revealing that the latest vaccine candidate has fewer side effects than their first.